Policy for Coronavirus Disease-2019
Tests During the Public Health
Emergency (Revised)
https://www.fda.gov/media/135659/download

(side 8)
FDA believes that 15 business days is a reasonable period of time to prepare an EUA
submission for a test that has already been validated.

Altså ikke en godkjenning innen 15 dager men direkte oversatt:

FDA mener at 15 virkedager er en rimelig periode for å forberede en EUA-innsending
for en test som allerede er validert.

Validering:
https://www.fda.gov/media/135659/download
Side 8

Validation
All clinical tests should be validated prior to use. In the context of a public health emergency, it
is critically important that tests are validated because false results can negatively impact not only
the individual patient but also can have broad public health impact. FDA has provided
recommendations regarding testing that should be performed to ensure analytical and clinical
validity in section V below. FDA encourages laboratories to discuss any alternative
technological approaches to validating their test with FDA through CDRH-EUATemplates@FDA.HHS.GOV.


Antigen tester:
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FDA defines SARS-CoV-2 antigen tests as those that detect proteins that are part of the SARSCoV-2 virus directly from clinical specimens. FDA recommends that the following validation
studies be conducted for a SARS-CoV-2 antigen test:
· Limit of Detection/Analytical Sensitivity
· Cross-reactivity/Analytical Specificity
· Microbial Interference
· Clinical Agreement Study
The clinical agreement study is intended to establish the performance characteristics (e.g.,
sensitivity/PPA, specificity/NPA) of the test. FDA believes that clinical agreement should be
established on human specimens, preferably leftover specimens from patients with or without
SARS-CoV-2 infection.
FDA has made available through download from our website, a template that antigen test
developers may choose to use to facilitate the preparation, submission, and authorization of an
EUA for an antigen test. *See more information in Section VI. For antigen tests, the template
includes further recommendations concerning the above validation studies and make additional
recommendations about other information that should be provided to FDA as part of the preEUA/EUA submission process. Developers can use alternative approaches. FDA encourages
developers to discuss any alternative approaches to validating their test with FDA through
CDRH-EUA-Templates@FDA.HHS.GOV.


*see more information section Vl
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VI. Availability of EUA Templates
FDA has made available through download from our website20 a series of templates that
developers may choose to use to facilitate the preparation, submission, and authorization of an
EUA for various types of COVID-19 tests. The templates reflect FDA’s current thinking on the
data and information that developers should submit to facilitate the EUA process. The templates
provide information and recommendations, and we plan to update them as appropriate as we
learn more about the COVID-19 disease and gain experience with the EUA process for the
various types of COVID-19 tests.
Developers can use alternative approaches. Developers who intend to use alternative approaches
should consider seeking FDA’s feedback or recommendations to help them through the EUA
process. FDA encourages developers to discuss any alternative technological approaches to
validating their test with FDA through CDRH-EUA-Templates@FDA.HHS.GOV.
Members of the public can submit questions about the templates to CDRH-EUATemplates@FDA.HHS.GOV, or they can submit comments regarding the templates to the public
docket established for this guidance.

Template:
https://www.fda.gov/media/137907/download

Tests should demonstrate a minimum sensitivity of ≥ 80% for all sample types submitted.
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General FAQs
Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (New 6/17)
A: During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions; and we have implemented a triage program to prioritize submissions based on several factors. As a result of these efforts, by June 1, 2020, FDA had authorized over 125 diagnostic and serological tests, far exceeding the number of test EUAs issued during previous emergencies.

As explained in FDA's guidance "Emergency Use Authorization of Medical Products and Related Authorities," starting on page 18, FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (e.g., point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need (e.g., at-home specimen collection; at-home testing), and the availability and adequacy of the information concerning the likelihood that the product may be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (e.g., the quantity and manufacturing capacity).

FDA strives to review Pre-EUA and EUA requests as quickly as we can. FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with you when their review is complete or if there are questions. If you have not yet been assigned a lead reviewer for your pre-EUA or EUA request, we recommend that you refer to the available resources to help you with your planning and submitting your EUA request:

SARS-CoV-2 IVD EUAs (Letters of Authorization and Instructions for Use/EUA Summaries)
EUA Templates with recommendations to help facilitate EUA requests, as explained in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
FAQs on Testing for SARS-CoV-2
Additionally, FDA's Policy for Coronavirus Disease-2019 Tests guidance includes recommendations intended to help accelerate the availability of COVID-19 tests in the United States for the duration of the public health emergency under certain circumstances. As explained in this policy, FDA does not intend to object to the development, distribution, and use of some tests prior to or without an EUA, as outlined in the guidance. Please refer to this policy for more information.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2